The FDA issues emergency authorization for the Johnson & Johnson COVID-19 vaccine

WASHINGTON – The United States is receiving a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday eliminated a single-dose Johnson & Johnson shot instead of two.

Health experts are looking forward to a full option to help speed up vaccinations as it fights a virus that has already killed more than 510,000 people in the United States and is moving in increasingly worrying ways.

The FDA said the J&J vaccine provides strong protection against what matters most: serious illness, hospitalizations and death. One dose was 85% protection against the most severe COVID-19 disease in a massive study on three continents – protection that has remained strong even in countries such as South Africa, where the most worrying variants are spreading.

“This is very good news,” Dr. Francis Collins, director of the National Institutes of Health, said Saturday. “The most important thing we can do now is to get as many shots in as many arms as possible.”

Shipments of several million doses to be split between states could begin as early as Monday. By the end of March, J&J said it expects to deliver 20 million doses in the United States and 100 million by summer.

J&J is also seeking authorization for the emergency use of its vaccine in Europe and from the World Health Organization. Globally, the company aims to produce approximately 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain became the first to eliminate its use.

On Sunday, a US advisory committee will meet to recommend how to prioritize single-dose vaccine use. And a big challenge is what the public wants to know: what type of vaccine is better?

“In this environment, whatever you can get – you get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory group that voted unanimously Friday that the benefits of the vaccine outweigh its risks.

The data is mixed on how well all vaccines used around the world work, leading to reports in some countries of one guy’s refusal to wait for another.

In the US, two-dose photos of Pfizer and Moderna were 95% protection against symptomatic COVID-19. The efficacy of a single 85% dose of J&J against severe COVID-19 decreased to 66% when moderate cases were introduced. But there is no comparison between apples and apples, because of the differences between when and where each company conducted its studies, with Pfizer and Modern Research ended before the variants began to spread.

Collins NIH said evidence of efficacy shows no reason to favor one vaccine over another.

“What do people think I’m most interested in preventing me from really getting sick?” said NIH’s Collins. “Will it keep me from dying of this terrible disease?” The good news is that all of this is happening. “

J&J is also testing two doses of the vaccine in a large separate study. Collins said that if a second dose is finally considered better, people who received one earlier will be given another.

The FDA has warned that it is too early to find out if someone with a mild or asymptomatic infection despite vaccination can spread the virus.

There are clear benefits in addition to the convenience of a single photo. Local health officials are looking to use the J&J option in mobile vaccination clinics, shelters for the homeless, even with sailors who spend months on fishing vessels – communities where it’s hard to be sure someone will return in threes. up to four weeks for the second vaccination.

The J&J vaccine is also easier to handle, lasting three months in the fridge compared to the Pfizer and Moderna options, which need to be frozen.

“We’re fighting a little bit to get more supplies. That’s the limiting factor for us right now,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staff were preparing electronic medical records, staffing and vaccine storage in advance. . to provide J&J photos soon.

The FDA said the studies did not detect any serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J vaccine are pain at the injection site and flu-like fever, fatigue and headache.

The FDA said there was a “distant chance” that people would experience a severe allergic reaction to the blow, a risk rarely seen with Pfizer and Moderna vaccines.

The vaccine has been authorized for emergency use in adults over 18 years of age. But, like other vaccine manufacturers, J&J is about to start a study of its vaccine in teens before moving to younger children during the year and is also planning a study in pregnant women.

All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that covers it. But they are done in very different ways.

J & J’s shot uses a virus as cold as a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to create the immune system where the real virus appears. It is the same technology used by the company to manufacture an Ebola vaccine and similar to COVID-19 vaccines manufactured by AstraZeneca and China CanSino Biologics.

Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that stimulates cells to make those harmless copies of the tips.

The AstraZeneca vaccine, already used in the UK and many other countries, completes a major US study required for FDA approval. Also in the pipeline, Novavax uses a still different technology, made with laboratory-grown copies of the spike protein, and reported preliminary findings from a British study suggesting strong protection.

Still other countries use “inactivated vaccines” made with coronavirus killed by Chinese companies Sinovac and Sinopharm.

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Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to the report.

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